Cleared Traditional

K130065 - BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K130065 · Biosonic Technologies, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
475d
Days
Class 2
Risk

K130065 is an FDA 510(k) clearance for the BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Biosonic Technologies, LLC (Laguna Niguel, US). The FDA issued a Cleared decision on April 30, 2014 after a review of 475 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Biosonic Technologies, LLC devices

Submission Details

510(k) Number K130065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2013
Decision Date April 30, 2014
Days to Decision 475 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
327d slower than avg
Panel avg: 148d · This submission: 475d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

All 76
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K130065.
Ulike Clear Zero (YC10 BU)
K260895 · Guangxi Ulike Medical Technology Co., Ltd. · May 2026
DeepSkin (DEP100)
K252621 · El Global Trade, Ltd. · May 2026
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
K252146 · Shenzhen Siken 3D Technology Development Co., Ltd. · Dec 2025
Aura Glide (FC40)
K252187 · Aura Medical, LLC · Dec 2025
Medi Lift Essential Eye Mask
K250618 · Ya-Man, Ltd. · Oct 2025
JOVS Electric Stimulation Beauty Device (JE2)
K250227 · Shenzhen Qianyu Technology Co., Ltd. · Oct 2025